UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012651 |
|---|---|
| Receipt number | R000014789 |
| Scientific Title | Genetic analysis for schizophrenia and mood disorders |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2021/12/27 13:12:52 |
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Basic information
Public title
Genetic analysis for schizophrenia and mood disorders
Acronym
Genetic analysis for schizophrenia and mood disorders
Scientific Title
Genetic analysis for schizophrenia and mood disorders
Scientific Title:Acronym
Genetic analysis for schizophrenia and mood disorders
Region
| Japan |
Condition
Condition
Schizophrenia, mood disorders and healthy controls.
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to clarify the pathology of schizophrenia and mood disorders by genetic analysis to investigate single nucleotide polymorphisms and promoter methylation.
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments of clinical symptoms, single nucleotide polymorphisms and promoter methylation in comparison with those of schizophrenia and mood disorders.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Drawing blood, questionnaires and medical interviews for schizophrenia patients, mood disorder patients and healthy controls.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diagnoses of schizophrenia and mood disorders of age 16 and over, who are inpatients or outpatients, and healthy controls who volunteer to participate in the study after receiving an adequate explanation of it.
Key exclusion criteria
Those with severe physical illness, people judged not suitable by doctor
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
kkondo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
1058461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
kkondo@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Japan Tobacco inc., Virus Ikagaku Kenkyusho Inc.
IRB Contact (For public release)
Organization
the Ethics Committee of the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学附属病院（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、医療法人常心会川室記念病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control sampling
Management information
Registered date
| 2013 | Year | 12 | Month | 21 | Day |
Last modified on
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014789
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
